Primary Talent Partners
Reliability Engineer II (Medical Devices)
Primary Talent Partners, Mounds View, Minnesota, United States
Reliability Engineer II (Medical Devices)
Primary Talent Partners is hiring a Reliability Engineer II for a 5‑month contract with a medical device client in Mounds View, MN. The role may be extended. Pay: $35.00–$45.00/hr. W2 contract, no PTO, no benefits. ACA‑compliant supplemental package available.
Description
Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
Complete risk analysis studies of new design and processes.
Compile and analyze performance reports and process control statistics; investigate and analyze relevant variables potentially affecting product and processes.
Ensure that corrective measures meet acceptable reliability standards.
Analyze preliminary plans and develop reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
May develop mathematical models to identify units, batches or processes posing excessive failure risks.
Propose changes in design or formulation to improve system and/or process reliability as necessary.
Determine units and/or batches requiring environmental testing, and specify minimum number of samples to obtain statistically valid data.
Key Responsibilities
Complaint trending
Risk document updates
Supporting change orders
Education & Experience Education Required: Bachelor’s degree, Engineering discipline preferred.
Years of Experience Required: 3–4 years.
Core Skills
Risk Management
Trending
Good Documentation Practices
Additional Must-Have Skills
Good technical‑writing skills – candidate will write complaint summaries, investigations and analysis summaries on the complaints.
Good communication skills.
1+ years of experience in complaint handling or customer service/technical support.
Nice to Have Skills
Change control of Medical Devices.
3+ years of experience in the medical device industry, with a strong background in Non‑Conforming Materials Reports (NCMR), CAPA, or product quality management.
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
Strong project management skills, with the ability to manage multiple priorities and deadlines.
Excellent problem‑solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
Proficiency in Microsoft Office Suite and quality management systems (QMS).
Seniority Level Entry level
Employment Type Contract
Job Function & Industries Engineering and Information Technology; Medical Equipment Manufacturing
EEO Statement Primary Talent Partners is an Equal Opportunity / Affiliated Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com.
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Description
Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
Complete risk analysis studies of new design and processes.
Compile and analyze performance reports and process control statistics; investigate and analyze relevant variables potentially affecting product and processes.
Ensure that corrective measures meet acceptable reliability standards.
Analyze preliminary plans and develop reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
May develop mathematical models to identify units, batches or processes posing excessive failure risks.
Propose changes in design or formulation to improve system and/or process reliability as necessary.
Determine units and/or batches requiring environmental testing, and specify minimum number of samples to obtain statistically valid data.
Key Responsibilities
Complaint trending
Risk document updates
Supporting change orders
Education & Experience Education Required: Bachelor’s degree, Engineering discipline preferred.
Years of Experience Required: 3–4 years.
Core Skills
Risk Management
Trending
Good Documentation Practices
Additional Must-Have Skills
Good technical‑writing skills – candidate will write complaint summaries, investigations and analysis summaries on the complaints.
Good communication skills.
1+ years of experience in complaint handling or customer service/technical support.
Nice to Have Skills
Change control of Medical Devices.
3+ years of experience in the medical device industry, with a strong background in Non‑Conforming Materials Reports (NCMR), CAPA, or product quality management.
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
Strong project management skills, with the ability to manage multiple priorities and deadlines.
Excellent problem‑solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
Proficiency in Microsoft Office Suite and quality management systems (QMS).
Seniority Level Entry level
Employment Type Contract
Job Function & Industries Engineering and Information Technology; Medical Equipment Manufacturing
EEO Statement Primary Talent Partners is an Equal Opportunity / Affiliated Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com.
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